Completed PHASE2 INTERVENTIONAL NCT00104260

Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin™ Treatment in Subjects With Phenylketonuria

A Phase 2, Multicenter, Open-Label Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin™ Treatment in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels

Sponsor: BioMarin Pharmaceutical

Conditions Phenylketonurias

Interventions sapropterin dihydrochloride

Updated 6 times since 2017 Last updated: Apr 5, 2007 Started: Dec 31, 2004 Completion: Nov 30, 2005

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Phenylketonurias, this trial is completed. The trial is conducted by BioMarin Pharmaceutical and has accumulated 6 data snapshots since 2004. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE2

First recorded

Dec 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

BioMarin Pharmaceutical

Data source: BioMarin Pharmaceutical

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Boston, United States , Chicago, United States , Dallas, United States , Los Angeles, United States , Madison, United States , Minneapolis, United States , New Haven, United States , New York, United States , Oakland, United States , Pittsburgh, United States and 3 more locations